At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label, Single-Bolus, 2-Period, Multi-Dose Level, 3 Cohort Crossover Design, Pharmacokinetic/Pharmacodynamic Study of Lusedra (Fospropofol Disodium) Injection Compared With Propofol Injectable Emulsion
In Brief
A Phase 4 clinical trial evaluating Fospropofol disodium, propofol for Anesthesia. Completed, enrolled 36 participants across 1 site.
Detailed Summary
This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol. In addition, the study will compare the maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.
Study Details
Timeline
Interventions
Two Treatment Periods: fospropofol disodium 6.5 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 0.65 mg/kg IV bolus, or propofol injectable emulsion 0.65 mg/kg IV bolus followed by fospropofol disodium 6.5 mg/kg IV bolus.
Two Treatment Periods: fospropofol disodium 10.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.0 mg/kg IV bolus, or propofol injectable emulsion 1.0 mg/kg IV bolus followed by fospropofol disodium 10.0 mg/kg IV bolus.
Two Treatment Periods: fospropofol disodium 15.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.5 mg/kg IV bolus, or propofol injectable emulsion 1.5 mg/kg IV bolus followed by fospropofol disodium 15.0 mg/kg IV bolus.